Medical Imaging: Less is More?

This past Monday (March 7, 2011), a 3D mammogram was performed in the United States for the first time and subsequent news stories have served to renew and escalate old controversies surrounding cancer screening. On the one hand, proponents argue that mammograms detect “between 80 and 90 percent of all breast cancers” (Ashton, 2011), allowing early treatment. Critics, however, point to several drawbacks: cost of the machines, radiation exposure, over diagnosis, false negatives and false positives. The 3D technique is expected have mixed results with respect to conventional mammography. Though it may reduce false positives and increase detection by 7%, it will nonetheless cost more, expose women to additional radiation and may not reduce the incidents of benign masses being discovered and treated as tumors (Salahi, 2010).

At this point, experts are saying that no detection strategy is perfect and it will take time to determine whether or not the new technique will save lives (Ashton, 2011; Salahi, 2010). In the meantime, the United States is a major consumer of diagnostic imaging equipment, having among the highest diffusion rates of mammographs, CT scanners, and MRI machines among OECD nations (OECD, 2010). It also spends more for health care on a per capita basis than any other OECD nation while ranking 25th in life expectancy (OECD, 2010). From this perspective, it is logical to ask whether technology – particularly unproven technology – is the key to good public health.

Image1

Source: OECD, 2010 

 

Image2
Source: OECD, 2010 

But non-3D mammography is not new; regular screening for women over 40 was first recommended by the American Medical Association in 1989 (Kevles, 1997). It seems that information accumulated over the past 22 years would give some insight into the efficacy of mammography. On this, the data are inconclusive. Howard, Richardson, and Thorpe (2009) found that the United States’ more aggressive screening program finds a higher breast cancer incidence rate, but results in a higher 5-year survival rate and a lower mortality rate than many European countries. However, they also state that the data do not necessarily indicate that more mammograms produce better outcomes.

Similar confusion can be found in OECD data. Although not an exact indicator of health, potential years of life lost (PYLL) may provide insight into the occurrence of premature, preventable death from a specific condition (OECD, 2010). If mammography were effective, one would expect higher screening rates to be correlated with lower PYLL values from breast malignancies, but this is not necessarily the case.

Image4
Source: OECD, 2010 

Given such questionable efficacy, one might ask how much cancer screenings are costing the public. At least one study concluded that even though the cost of diagnostic imaging equipment is growing, it has remained constant at 10% of hospital expenditures (Beinfeld & Gazelle, 2005). Hence medical imaging is not the only factor in rising spending. Ultimately, medical imaging costs are at the center of the struggle between health care providers’ best judgment, the medical device industry profit motive, medical insurance cost management, federal regulatory and investment policy, and the R&D that scientists and companies wish to pursue. This is a complex system to say the least.

If there is one possible path to a better system, it might be found by studying Japan. In 2004, Japan spent about half what the US did on health care per person; its population has a longer life expectancy, and its PYLL due to breast cancer is among the lowest in the OECD. It seems they are doing something right.

Image4
Source: OECD, 2010

References

Ashton, J. (2011). 3D mammogram newest weapon against breast cancer. CBS Evening News. Retrieved from http://www.cbsnews.com/stories/2011/03/07/eveningnews/main20040349.shtml.>

Beinfeld, M. T., & Gazelle, G. S. (2005). Health Policy and Practice Radiology Diagnostic Imaging Costs: Are They Driving Up the Costs of Hospital Care? Radiology, 235(3), 934-939.

Howard, D. H., Richardson, L. C., & Thorpe, K. E. (2009). Cancer screening and age in the United States and Europe. Health Affairs, 28(6), 1838. Health Affairs. Retrieved March 11, 2011, from http://content.healthaffairs.org/cgi/content/abstract/28/6/1838.>

Kevles, B. H. (1997). Naked to the bone: Medical imaging in the twentieth century. Naked to the bone Medical Imaging in the Twentieth Century. New Brunswick, NJ: Addison-Wesley.

OECD. (2010). OECD Health Data. OECD Health Statistics. Retrieved from http://www.ecosante.org.ezproxy1.lib.asu.edu/index2.php?base=OCDE&langs=E...

Salahi, L. (2010). 3D Mammogram on the Brink of FDA Approval. ABC News. Retrieved from http://abcnews.go.com/Health/OnCallPlusBreastCancerNews/3d-imaging-detects-br...

 

 

Science Policy’s New TRICKS

In the early 1990s, Charles Mistretta, supported in part by the National Institutes of Health (NIH) (Korosec, Frayne, Grist, & Mistretta, 1996), was working on a technology that promised to replace invasive angiography for the diagnosis of painful conditions such as peripheral vascular disease. The Time-Resolved Imaging of Contrast KineticS, or TRICKSTM was patented in 1996 by the Wisconsin Alumni Research Foundation and licensed to GE Healthcare, who brought it to market in 2003 (Association of University Technology Managers, 2006).

TRICKS - Assess blood flow dynamics and visualize even small caliber vessels

TRICKS static image of the head.
Source: https://www2.gehealthcare.com/

Yet, had TRICKS been developed 25 years earlier, it might not have been commercialized. The relatively smooth transition from laboratory to clinic was in part due to legislation that was pioneered by the NIH.

In the 1970s, US policy mandated that the government owned any invention developed with federal funds. However, the belief was starting to emerge that this policy was stifling commercialization of new technologies. The issue became particularly salient after the British firm EMI sold its first CT scanners even though a solid foundation for the technology had been laid in the United States (Kevles, 1997). The National Institutes of Health (NIH) had already taken notice of its poor commercialization record and realized that the public was not benefitting from the basic scientific discoveries for which it had paid. In 1968, the NIH initiated the Institutional Patent Agreement (IPA), giving participating research institutions the right to patent and license inventions developed in their laboratories using federal funds. This program was seen as so successful that it was adopted by the National Science Foundation (NSF) in 1973 and extended to all federal agencies in 1980 with the passage of the Bayh-Dole Act (Bremer, Allen, & Latker, 2009).

Ipas
Patenting by Carnegie research universities, by IPA status. (Click to expand.) Source: (Bremer, Allen, & Latker, 2009, p. 7).

Combined with the Stevenson-Wydler Technology Innovation Act of 1980 and the Federal Technology Transfer Act of 1986, the foundation had been laid for new medical imaging devices to transition smoothly from universities to private industry, with compensation paid to the original researchers.

Although the true impact of the technology transfer programs is far from certain, circumstantial evidence suggests that they served to spur private investment in research and development (R&D). Though already on an upward trend, industrial investment in technology surpassed that of the government just as the Bayh-Dole Act was being signed. Private investment has continued to show steady gains ever since. In 2008, industry was responsible for about 84% of all development investments and 61% of applied research (National Science Foundation, 2010).

Rd_by_source

Total R&D investment is dominated by private firms. Source: National Science Foundation, 2010.


Dev_by_source

The majority of research dollars go to fund technological development; basic and applied research collectively make up only 40% of the US portfolio. Source: National Science Foundation, 2010.

References

Association of University Technology Managers. (2006). Technology Transfer Stories: 25 Innovations that Changed the World: the Better World Report. Northbrook, IL. Retrieved February 18, 2011, from http://www.immagic.com/eLibrary/ARCHIVES/GENERAL/AUTM_US/A060315S.pdf.>

Bremer, H., Allen, J., & Latker, N. J. (2009). The Bayh-Dole Act and Revisionism Redux. Life Sciences Law & Industry Report, 3(17), 1-14. doi: 10.1080/09654310802513864.

Kevles, B. H. (1997). Naked to the bone: Medical imaging in the twentieth century. Naked to the bone Medical Imaging in the Twentieth Century. New Brunswick, NJ: Addison-Wesley.

Korosec, F. R., Frayne, R., Grist, T. M., & Mistretta, C. A. (1996). Time-resolved contrast-enhanced 3D MR angiography. Magnetic Resonance in Medicine, 36(3), 345–351. Wiley Online Library. Retrieved February 18, 2011, from http://onlinelibrary.wiley.com/doi/10.1002/mrm.1910360304/abstract.>

National Science Foundation. (2010, March). National Patterns of R&D Resources: 2008. Retrieved February 24, 2011, from http://www.nsf.gov/statistics/nsf10314/content.cfm?pub_id=4000&id=2.

Government policy on basic and applied research as seen through CT

 

British Development of Computed Tomography

Modern medical imaging has its roots in the private research of interested individuals curious about the properties of X-rays and how they could be used to create images of the inner workings of the human body. The development of the computed tomography (CT) in 1971 was aided by the private research labs of Electric & Musical Industries Ltd. (EMI) where the concept of measuring X-ray absorption rates in tandem with computer analysis to create images was founded. EMI was uncertain of the economic viability of a CT scan and so funding and cooperation with the British Department of Health and Social Security was established under the context of seeking to image the brain without costly surgery. In this case the private industry had developed the basic science behind the technology but was dependant on the government to help fund a working medical imaging device.

 

Brain_scan_picture4

 Focusing on capturing images of the brain helped convince the DHSS to fund EMIs development of computed tomography. Image Source NINDS.NIH.gov

 

American Development of Computer Tomography

Meanwhile in the United States it has been noted that there was little in the way of government interest in funding development of CT due to a lack of clinical plan applications. At the time the National Institute of Health (NIH) was more interested in funding basic or pure science research and hesitant to pursue the development of instruments or medical imaging devices. While there was little government interest in the United States for funding research and development of a CT scanner the end result was a combination of the work of publicly funded academic institutions and industry. As Bettyann Kevles (1997) notes “while the basic ideas were largely in the public domain by the time industry entered the picture, industry developed them by subsidizing advanced research and hiring away experts in exchange for having as show-window for what it expected would be its new product” (p. 185).


Ctscanner
The modern computed tomography machine would not have been possible without the combined efforts of the public and private sectors. Image source: NASA.gov

 

Structural Differences

The differences in the British and American funding can be attributed to their different organizational and funding systems. While the British had developed system of unitary administrative oversight the American system was divided more into areas of technique. As Stephen Toulmin (1964) notes “Britain may perhaps learn from American experience… one and the same technique may well contribute to the national life in half-a-dozen ways and so interest several government departments” (p. 358). This division would have led CT development in the United States to be under the interest of the NIH which was lacking interest in funding development, yet in Britain the unitary style of oversight was more politicized and saw the political and social welfare value of brain images obtained through CT. Had the US government been under a politicized unitary oversight system development of CT instruments might have found greater consideration but as Toulmin (1964) further notes that under unitary oversight systems science and technology funding can become “not a technical choice, but a political one” (p. 354) which could favor applied research, which requires as a base, yet at the same time may jeopardize basic or pure research.

Without the prior government investment in the research and development of physics and computers it is unlikely that industry would have had the components necessary to create and develop medical imaging instruments. Conversely without private industry the public may have been delayed access to advances in medical imaging. If either the private or public institutions had not contributed through basic or applied research the development of functional advance imaging technologies could have been delayed or required additional resources one side to make up or failures of the other.

 

 

 

Reference

Doby, T., & Alker, G. (1997). Origins and Developments of Medical Imaging. Carbondale: Southern Illinois University.

Kevles, B. H. (1997). Naked to the bone: Medical imaging in the twentieth centuryNaked to the bone Medical Imaging in the Twentieth Century. New Brunswick, NJ: Addison-Wesley.

Toulmin, Stephen (1964), “The complexity of scientific choice: A Stocktaking,” Minerva 2(3): 334-359

 

 

 

X-Rays and MRIs: The role of government policy and investment

Many forces acted to build the wide variety of medical diagnostic machines in common use today. However, this entry will focus specifically on government policy and its role in the development of radiology (X-rays) and MRIs (magnetic resonance imaging). These two stories, though separated by 80 years and 4,000 miles, show distinct and interesting parallels. 

Radiology

Once X-rays had been discovered in Germany by Wilhelm Roentgen in 1895, medical diagnostic radiology developed at an astounding pace, but occurred primarily in companies and without Roentgen’s direct involvement. Although he surely understood the value of the invention, he chose not to patent the technology (Doby & Alker, 1997). The reason for his choice is unclear, although it was likely due – at least in part – to his personal ideology, “To Roentgen, science was a calling, an almost religious obligation to expand knowledge of the natural world” (Kevles, 1997, p. 19). However, it is also possible that he was deterred by the high cost of German patents (at least DM 30 per year) that, in exchange, gave inventors only limited recourse against infringement. The German patent system at the time was priced to “eliminate protection for trivial inventions and was meant to “foster economic development” (not necessarily by protecting the rights of the original inventor) (Khan, 2010). Many applications of Roentgen’s discovery followed, including the fluoroscope by Thomas Edison. Yet Wilhelm Roentgen continued to live the simple life of a professor, albeit a very well-known professor, even donating the proceeds of his Nobel Prize to his university.

Wilhelm Conrad Roentgen
Source: www.odec.ca

Magnetic Resonance Imaging

The naissance of MRI took place in a different context from radiology – though the outcome was much the same. In contrast to 19th century Germany, the United States in the 1970s supported (at least in theory) basic science through government grants and economic growth via a relatively inexpensive patent system geared toward protecting the rights of the original inventor. And so it was in this environment that Raymond Damadian and Paul Lauterbur were separately trying to develop MRI machines for practical medical applications. They were operating on small grants from the National Cancer Institutes and the National Heart and Lung Institutes, but MRI technology is quite complicated and significantly larger investments would be needed to bring such a product to market. In response to a grant proposal from Damadian, the National Institutes of Health refused to provide funding for such development research; its preference was for basic science. Thereafter he, as well as Lauterbur, applied separately for patents in hopes of perfecting, and profiting from, their medical devices. In this regard, Damadian succeeded in obtaining multiple patents but Lauterbur was defeated by high attorney fees and a one-year statute of limitations after initial discovery. Although both scientists attempted to secure private funding, investments were difficult to come by and ultimately, as with X-rays, MRI machines were commercialized by large companies such as General Electric (GE) that, at least initially, did not pay fees to either scientist. In the end, however, Damadian’s patent did result in a $100 million settlement from GE in 1995 (Kevles, 1997). Lauterbur, though he did not receive the profits he was hoping for, was compensated with a Nobel Prize in 2003.

 

Raymond V. Damadian   Paul C. Lauterbur

Raymond V. Damadian 
Source: http://opentopia.com

Paul C. Lauterbur 
Source: http://indianautographs.com

Patents and Scientific Funding

It is interesting to consider the role of patents and funding for basic research in the development of these medical imaging devices. Clearly, in both cases, dedicated scientists in positions that supported basic scientific exploration were key factors. Even if Damadian and Lauterbur were motivated purely by the promise of future profits, they were standing on the shoulders of generations of basic scientific giants.

The role of the patent is somewhat murkier, and seems to pale in importance to the availability of capital. In both cases, it seems, the technology became available to the medical community and innovators were compensated either by science or by industry. But are the funding and incentive structures sufficient to ensure ongoing technological development? 

Although one might conclude, based on Damadian’s story, that government agencies such as the National Science Foundation (NSF) and the National Institutes of Health should expand their purview to include development research, this would not be a new debate. The goals of these offices date back to the end of World War II when, after years of political and ideological wrangling, defeats and compromise, the members of the first NSF board of directors declared in 1951 that “the principal function of the Foundation was to advance basic scientific research and training, and that alone” (Kevles, 1978, p 364). Hence, in an era of rapidly-changing technology, efficient financial systems, and pervasive information flows, perhaps the future of economic development would be best served by re-examining the patent system.

Image from Damadian's Patent 7196519: Stand-up vertical field MRI apparatus
Source: freepatentsonline.com

References

Doby, T., & Alker, G. (1997). Origins and Developments of Medical Imaging. Carbondale: Southern Illinois University.

Kevles, B. H. (1997). Naked to the bone: Medical imaging in the twentieth century. Naked to the bone Medical Imaging in the Twentieth Century. New Brunswick, NJ: Addison-Wesley.

Kevles, D. J. (1978). The Physicists. New York: Knopf.

Khan, Z. (2010). An Economic History of Patent Institution. EH.net. Retrieved February 10, 2011, from http://eh.net/encyclopedia/article/khan.patents.>

 

 

Blog Post 1: Medical Imaging Development

While the history of medical imaging can be traced back to as early as 290 B.C.E. with the royal treasury of Egypt funding libraries and scholarly study of the human anatomy, medical imaging in its current form techniques began around the turn of the 19th century with the identification of the X-ray. Since then, imaging has been primarily a diagnostic tool, generally believed to improve patient care and reduce health care costs due to early detection of diseases through less-invasive and non-surgical techniques.

Radiology

Medical imaging consisted of autopsies and drawings until 1895 when Wilhelm Roentgen was working with cathode ray tubes replicating experiments conducted by Heinrich Hertz. With the cathode emitting rays Roentgen found photographic plates became fogged, which turned out to be from rays being emitted by the cathode interacting with a barium platinum cyanide screen. After investigation he found that the rays from the cathode tube could penetrate objects and illuminate the screen to different degrees dependent upon the presence of bone and skin between the cathode tube and screen. .The effects of X-rays had been seen years earlier through their effect on photographic plates but the phenomenon was disregarded until Roentgen witnessed the same phenomenon and became fascinated1 If not for Roentgens interest the development of medical imaging may have been delayed indefinitely. The dissemination of this finding was remarkable as was the refinement of the quality of X-ray images and reduction of required exposure time. Because X-rays only revealed limited soft tissue methods for imaging arteries and organs were developed which led to advances in imaging contrasts and catheters.2 The use of glass in fiber optics also owes part of its advancement to medical imaging as it was developed to view complex internal organs.3 Medical imaging was not without benefit from other technologies. The development of induction coils, television image amplifying vacuum tubes, transistors and many other innovations added to the strength and precision of X-ray images.

Medimg4

A giant leap forward in medical imaging came from integrating computers. Cross-sectional images could be created by measuring absorption rates of x-rays from different angles. To generate an image from the large amounts of data and even to measure the data required the processing power of a computer. This cross-sectional image came to be known as computed tomography or CT.4 The first CT scan was taken on October 1, 1971 and was financed by Electric and Musical Industries which was at the time reaping the rewards of its recently produced album Sergeant Pepper’s Lonely Heart’s Club Band.5

 

TED Talk about the rapid development in computer aided medical imaging.

 

Ultrasound

Ultrasound was first widely used during World War II to detect enemy submarines. After WWI, ultrasound was applied to produce low-quality 2D images of human organs. As the quality improved in the 1970s and 80s, ultrasound not only allowed babies to be viewed in utero, but its images also enabled the effectiveness of cancer treatments on tumors to be assessed.6

Medimg3

Nuclear medicine

Nuclear imaging (such as Positron Emission Tomography [PET]) is the culmination of many important discoveries beginning with that of natural radioactivity. The development of ultrasound was helped by the government but nuclear medicine was hindered when publications were suppressed during World War II to keep new development from reaching the Axis.7 The application of radiation to medicine is attributed to Jean Joliot-Curie, the first high commissioner for the French Alternative Energies and Atomic Energy Commission in 1946. Although its first success was in diagnosis abnormal thyroid conditions and results of a PET scan were used in court to confirm a defendant suffered from schizophrenia5, PET scans are now commonly used to discover cancerous tumors.8

Present and Future

Interestingly, all of the technologies discussed above are still in use for different applications; none have yet been rendered completely obsolete by newer devices. Of course, new techniques and applications are constantly being developed and they will undoubtedly have an ever increasing impact on not only the healthcare system, but also human culture.

Other technologies are giving researchers clues to human behavior by allowing them to watch the brain function in real time. This functional Magnetic Resonance Imaging (fMRI) technique even has the potential to move beyond the laboratory and may impact individuals’ expectations of privacy and other social norms. Although the claim is controversial, some believe that fMRI techniques can detect lying with about 90% accuracy.

Capture5555

 

Reference

Doby, T., & Alker, G. J. (1997). Origins and development of medical imaging. Carbondale: Southern Illinois University Press. p. 58

Films Media Group. (2006). The History of Medical Imaging. Films on Demand. Retrieved from http://digital.films.com.ezproxy1.lib.asu.edu/PortalViewVideo.aspx?xtid=37556

Doby, T., & Alker, G. J. (1997). Origins and development of medical imaging. Carbondale: Southern Illinois University Press. Chapter 7

Doby, T., & Alker, G. J. (1997). Origins and development of medical imaging. Carbondale: Southern Illinois University Press. p. 95-96

Doby, T., & Alker, G. J. (1997). Origins and development of medical imaging. Carbondale: Southern Illinois University Press. p. 108-111

Pietzsch, J. (2011). With a Little Help from My Friends. NobelPrize.org. Retrieved from http://nobelprize.org/nobel_prizes/medicine/laureates/1979/perspectives.html

Films Media Group. (2006). The History of Medical Imaging. Films on Demand. Retrieved from http://digital.films.com.ezproxy1.lib.asu.edu/PortalViewVideo.aspx?xtid=37556

Doby, T., & Alker, G. J. (1997). Origins and development of medical imaging. Carbondale: Southern Illinois University Press. p. 116-117

Films Media Group. (2006). The History of Medical Imaging. Films on Demand. Retrieved from http://digital.films.com.ezproxy1.lib.asu.edu/PortalViewVideo.aspx?xtid=37556

9 Films Media Group. (2006). The History of Medical Imaging. Films on Demand. Retrieved from http://digital.films.com.ezproxy1.lib.asu.edu/PortalViewVideo.aspx?xtid=37556